This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the papnet testing system
| Device | PAPNET (R) TESTING SYSTEM |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS |
| Date Received | 1994-09-21 |
| Decision Date | 1995-11-08 |
| Notice Date | 1996-12-11 |
| PMA | P940029 |
| Supplement | S |
| Product Code | MNM |
| Docket Number | 96M-0472 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940029 | Original Filing | |
| S003 | 1996-12-23 | Normal 180 Day Track |
| S002 | 1996-04-01 | Normal 180 Day Track |
| S001 | 1996-01-31 | Normal 180 Day Track |